||The objective of this course it to illustrate the commercialization process for biomaterials products. The features and the marketing overview of biomaterials will be introduced first. The regulatory issues and the necessary procedures for the commercialization process will be introduced. By the case studies, it is designed to train the students about the necessary concepts of product design, manufacturing and testing processes. It consists of the product design guidelines, ISO 13485 medical products GMP, pre-clinical and clinical tests.